MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT

Lot Number R23403

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Rash (2033); Burning Sensation (2146); Tingling (2171)

Event Date 03/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] rash [rash], burning/ everything is on fire/ hot feeling [burning sensation], stinging feeling [pain], tingling [paraesthesia], maybe this thermacare is reacting with the sulfamate antibiotic [drug interaction], slept with the wrap [device use error],.Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6)-year-old caucasian female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain, device lot number r23403, expiration date jun2019), via an unspecified route of administration from (b)(6) 2017 for back pain.Co-suspect medication included sulfamate antibiotic for urinary tract infection.Medical history included ongoing urinary tract infection.Concomitant medication included propanol (propanol).The patient slept with the wrap on from 11:30 at night on (b)(6) 2017 to about 2:30 in the morning on (b)(6) 2017.She woke up in the middle of the night to burning, a rash, and a stinging feeling in her chest, ears, neck, even on her mouth; terrible rash on her body from the back to front chest, her cheeks and ears are burning.It's even on her stomach and arms and all over her body.She can also feel the tingling and burning; like a stinging feeling, a hot feeling, like everything is on fire.She got up, removed the heatwrap and took a benadryl/ wal-dryl for the rash.The patient stated "it (benadryl/ wal-dryl) knocks me out and i had to go to the work and i only took one pill and it hasn't done anything", didn't work and the rash hasn't gone.The patient has been on the antibiotic three times last week and then received another prescription for additional 7 days.She confirmed that she hadn't experienced these rashes from the antibiotic before and never used heatwrap before.The patient reported "maybe this thermacare is reacting with the sulfamate antibiotic." the action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event device use error was recovered.The outcome of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (17may2017): follow-up attempts are completed.No further information is expected.Follow-up (15mar2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the event rash as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the event rash as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "a terrible rash on my body, " the cause of the consumer stating the wrap caused a terrible rash on my body, is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause an adverse event; skin irritation.A trend does not exist for this batch.Rsnbly suggest device malfunc? no; severity of harm: n/a; site sample status: not received.

Event Description

Event verbatim [preferred term] rash [rash] , burning/ everything is on fire/ hot feeling [burning sensation] , stinging feeling [pain] , tingling [paraesthesia] , maybe this thermacare is reacting with the sulfamate antibiotic [drug interaction] , slept with the wrap [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 44-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain, device lot number r23403, expiration date jun2019), via an unspecified route of administration from (b)(6) 2017 for back pain.Co-suspect medication included sulfamate antibiotic for urinary tract infection.Medical history included ongoing urinary tract infection.Concomitant medication included propanol (propanol).The patient slept with the wrap on from 11:30 at night on (b)(6) 2017 to about 2:30 in the morning on (b)(6) 2017.She woke up in the middle of the night to burning, a rash, and a stinging feeling in her chest, ears, neck, even on her mouth; terrible rash on her body from the back to front chest, her cheeks and ears are burning.It's even on her stomach and arms and all over her body.She can also feel the tingling and burning; like a stinging feeling, a hot feeling, like everything is on fire.She got up, removed the heatwrap and took a benadryl/ wal-dryl for the rash.The patient stated "it (benadryl/ wal-dryl) knocks me out and i had to go to the work and i only took one pill and it hasn't done anything", didn't work and the rash hasn't gone.The patient has been on the antibiotic three times last week and then received another prescription for additional 7 days.She confirmed that she hadn't experienced these rashes from the antibiotic before and never used heatwrap before.The patient reported "maybe this thermacare is reacting with the sulfamate antibiotic." the action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event device use error was recovered.The outcome of rash was not recovered.The outcome of the other events was unknown.The product quality complaint group reports that the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "a terrible rash on my body, " the cause of the consumer stating the wrap caused a terrible rash on my body, is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause an adverse event; skin irritation.A trend does not exist for this batch.Rsnbly suggest device malfunc? no; severity of harm: n/a; site sample status: not received.Follow-up (17may2017): follow-up attempts are completed.No further information is expected.Follow-up (15mar2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19dec2019): follow-up attempts are completed.No further information is expected.Follow-up(10feb2020): new information received from the product quality complaint group includes: investigation results., comment: based on the information provided, the event rash as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.A trend does not exist for this batch.No further investigations or actions is suggested at this time.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9257613
• MDR Text Key: 181930905
• Report Number: 1066015-2019-00294
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2019
• Device Lot Number: R23403
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROPANOL.; PROPANOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 54